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Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy (TICAP-DCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03129568
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Translational Research Informatics Center, Kobe, Hyogo, Japan
Information provided by (Responsible Party):
Hidemasa Oh, Okayama University

Brief Summary:
A phase 1 randomized-controlled study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Biological: CDC infusion Phase 1

Detailed Description:
This trial consists of 2 studies. Seven consecutive patients will be enrolled to a phase 1a study to verify the procedural feasibility and safety, followed by a phase 1b study to randomly assign 24 patients in a 1:1 ratio to the CDC infusion group and the control arm.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Transcoronary infusion
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy
Actual Study Start Date : April 14, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2023

Arm Intervention/treatment
Experimental: CDC infusion
CDCs infusion by coronary intervention.
Biological: CDC infusion
Injection of CDCs (0.3 million per kg of body weight).
No Intervention: Observation (Control group)
Coronary angiogram without placebo infusion.

Primary Outcome Measures :
  1. Number of Participants with Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. [ Time Frame: 6 months after CDC treatment ]
    Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.

Secondary Outcome Measures :
  1. Change in Ejection Fraction [ Time Frame: 6 months after protocol treatment ]
    To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants compared with controls from baseline to 6 months of follow up.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed as dilated cardiomyopathy.
  • Patients aged under 18 years old.
  • Cardiac ejection fraction < 40%.

Exclusion Criteria:

  • Contradiction to cardiac magnetic resonance imaging.
  • Cardiogenic shock.
  • A patient with unstoppable extracorporeal circulation.
  • A patient with lethal, uncontrollable arrhythmia.
  • A patient with a complication of coronary artery disease.
  • A patient with a complication of brain dysfunction due to circulatory failure.
  • A patient with malignant neoplasm.
  • A patient with a complication of a serious neurologic disorder.
  • A patient with high-grade pulmonary embolism or pulmonary hypertension.
  • A patient with high-grade renal failure.
  • A patient with multiple organ failure.
  • Active infection (including endocarditis).
  • Sepsis.
  • Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03129568

Contact: Hidemasa Oh, M.D., Ph.D. +81-086-235-6506
Contact: Shinichi Ohtsuki, M.D., Ph.D. +81-086-235-7250

Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: Hidemasa Oh, M.D., Ph.D.    +81-086-235-6506   
Contact: Shinichi Ohtsuki, M.D., Ph.D.    +81-086-235-7250   
Principal Investigator: Hidemasa Oh, M.D., Ph.D.         
Sponsors and Collaborators
Okayama University
Translational Research Informatics Center, Kobe, Hyogo, Japan
Study Chair: Shigeru Uemura, M.D., Ph.D. Shonan Tobu Clinic

Publications of Results:
Responsible Party: Hidemasa Oh, Professor, Okayama University Identifier: NCT03129568     History of Changes
Other Study ID Numbers: 01F1701003
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases